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FEATURED EDITORIAL

CDMO Capacity Crunch: Are Biotechs Wasting Time On The Wrong CDMO?

Biotechs often default to one of two flawed instincts: pursue the biggest name in the space or go with the lowest bidder. To avoid misalignment, look at these less visible factors.

GUEST COLUMNISTS

Why Your MES RFP Is Failing Before It Starts
Many manufacturing execution system requests for proposals fail. Not because vendors cannot deliver or the tech is immature, but because the requirements are written backward.
Here's How FDA's Accelerated Approval Pathway Has Evolved Since '24
FDA's accelerated approval guidance kicked off a rebalancing of new drug approval pathways. Since its 2024 release, the agency has been building on it in a few key areas.
Gaining An Edge In GLP-1 Production
The shortage-driven production of GLP-1 drugs of the past few years is giving way to a long-term operation model characterized by digital enablement and supply chain resilience.
How Generic Pharma Manufacturers Can Rebuild Margins Inside The Four Walls
The pricing dynamics for generic drugs turns formerly attractive products into high-volume, low-margin commodities. Lean and Six Sigma in four key areas can unlock efficiencies.
Causal Mechanism And Effect Analysis (CMEA): FMEA's Simpler, Effective Alternative
This article describes causal mechanism and effect analysis (CMEA) as an alternative to failure mode and effect analysis (FMEA) for analyzing and managing the industry’s risks.
The Stepwise Path Lilly Mapped From Paper To Digital Logbooks
Eli Lilly and Company started at the front lines, on the shop floor gathering operator input, when switching from paper to digital logbooks.
Minimizing Regulatory Risk For Biologics Manufacturing Changes
Any manufacturing process change for a biologic can raise comparability questions. Here’s a practical, action-oriented strategy to ensure health authorities are satisfied.
Building Quality Into Radiopharmaceuticals: A Look At EMA's Recent Guideline
The EMA's December 2025 draft guideline on expectations for the quality documentation of radiopharmaceuticals replaces the earlier 2007 guideline and reflects significant developments.

PHARMA OUTSOURCING WHITE PAPERS

Improvements In ADC Efficacy And Stability
Antibody–drug conjugates link antibodies to potent toxins, but increased hydrophobicity impairs stability, manufacturing, and PK, spurring interest in hydrophilic linker strategies.

Nucleic Acid-LNP Ultrafiltration And Diafiltration
Downstream filtration can make or break LNPs at scale. See how membrane format, loading, and shear affect recovery and stability — and how alternative TFF lowers scale‑up risk.
Overcoming Barriers To Membrane Technology: Demonstrating Protein A Affinity Capture Quality, Process Similarity
Explore how the interchangeable use of Protein A membrane and resin media can streamline your bioprocessing workflows, ensuring efficient, scalable, and high-quality manufacturing from lab scale to full-scale production.
Safe, Scalable And GMP-Ready DNA
Cell‑free synthetic DNA provides a scalable, safer alternative to plasmids by eliminating bacterial risks, simplifying quality control, and enabling complex sequences under GMP‑aligned conditions.
Inspecting On The Edge — Understanding Punch Tip Wear
Why is a horizontal optical comparator highly recommended for tablet manufacturers as a measuring tool for punch tip inspection, and what strategies can be used to detect, reduce, and prevent tip wear?
A Shift Towards Biofluorescent Particle Counters In Manufacturing
Sterility in injectable drug manufacturing is vital for patient safety and efficiency. Discover how biofluorescent particle counters revolutionize contamination control, regulatory compliance, and operational excellence in modern pharma.